PMA P880086S146
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S146
- Product code
- NVZ
- Decision date
- 2007-05-09
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE ZEPHYR XL SR MODEL 5626 PACEMAKER WHICH UTILIZES THE XL BATTERY MODEL 9438 WHICH IS CURRENTLY APPROVED FOR USE WITH THE MARKETED ZEPHYR XL DR 5826 PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZEPHYR XL SR MODEL 5626 AND IS INDICATED FOR SINGLE CHAMBER RATE ADAPTIVE PACING.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S146
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2007-05-09
- Decision code
- APPR
- Date received
- 2007-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ZEPHYR XL SR MODEL 5626 PACEMAKER WHICH UTILIZES THE XL BATTERY MODEL 9438 WHICH IS CURRENTLY APPROVED FOR USE WITH THE MARKETED ZEPHYR XL DR 5826 PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZEPHYR XL SR MODEL 5626 AND IS INDICATED FOR SINGLE CHAMBER RATE ADAPTIVE PACING.